NCT07573449已完成1 期
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]JNT-517 Following a Single Oral Dose in Healthy Male Participants
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年1月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
- •In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable).
- •History of a minimum of 1 bowel movement per day.
- •Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
排除标准
- •Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- •Alcohol consumption of >14 units per week.
- •A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- •Participants having taken an investigational drug within 30 days prior to screening.
- •Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months.
- •Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
- •Previous exposure to JNT-
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaNCT07295951Janssen Research & Development, LLC10
Unknown
1 期
[14C]YZJ-1139 在中国成年男性健康受试者体内的吸收、代谢和排泄临床试验-[14C]YZJ-1139 人体物质平衡及生物转化研究ChiCTR2100044302完全自筹6
已完成
1 期
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male ParticipantsNCT07308236Eisai Inc.10
进行中（未招募）
1 期
一项在健康男性参与者中评价[14C]JMKX003142 物质平衡和绝对生物利用度的研究多囊肾CTR20260792浙江杭煜制药有限公司
已完成
1 期
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)NCT07454863Dizal Pharmaceuticals6